Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

TruSignal Adult/Pediatric Sensor Recalled by GE Healthcare Finland Oy Due to There is a potential reduction of energy reaching...

Date: May 19, 2023
Company: GE Healthcare Finland Oy
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare Finland Oy directly.

Affected Products

TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

Quantity: 23537 devices

Why Was This Recalled?

There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Where Was This Sold?

Worldwide

About GE Healthcare Finland Oy

GE Healthcare Finland Oy has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report